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A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine5% v Lidocaine3.6%,Menthol1.25% | Active Comparator | Daily patch Q12 followed by Q12 of no patch |
|
| Lidocaine 3.6%, menthol 1.25% v placebo | Placebo Comparator | Daily patch Q12 followed by Q12 of no patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine 5% patch | Drug | 10cmx 14 cm transdermal patch sealed in its own pouch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten | Day ten |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day ten |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James J Ciullo, MBA | Contact | 6302512873 | jay@lidopatch.com | |
| Eric Castro, MD | Contact | 773-771-4160 | jedc269@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Good Sheppard Hospital | Recruiting | Barrington | Illinois | 60010 | United States |
Investigators plan to share the study results as a whole but no plans to share individual results.
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D057968 | Transdermal Patch |
| C511998 | Lidoderm |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| lidocaine 3.6%, menthol 1.25% | Drug | 10cmx 14 cm transdermal patch sealed in its own pouch |
|
|
| Placebo | Drug | patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch |
|
| Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale |
Statistical superiority sought for lidocaine 3.6%,menthol 1.25% compared to placebo. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. |
| Day 10 |
| Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day 10 |
| Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale | Endpoint is a non-inferiority statistical comparison. Comparison is based off of analysis of identical questionnaires administered at baseline and day ten. | Day 10 |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D004864 | Equipment and Supplies |